305 results
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25ms
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Sources: EU EUDAMED, US FDA
NUCLEAR ENTERPRISES 1600/GAMMA COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
STATSTRAP NEONATAL INCUBATOR SAFETY STRAP, MODELS SS-001, SS-002
FDA 510(k)
FDA Class 1
·General Hospital
EAGLE ENDO SPECIMEN RETRIEVAL BAG
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
BD PLASTIPAK¿ CONCENTRIC LUER LOCK SYRINGE
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·June 20, 2018
CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Malfunction
·EDWARDS LIFESCIENCES·Product code DYE·May 8, 2014
UPHOLD VAGINAL SUPPORT SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·October 23, 2012
PFC SIGMA/OV/DOME PAT 3PEG, 41
FDA Adverse Event
Injury
·DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS·Product code JWH·August 11, 2010
Moog Curlin Infusion, Ambulatory Infusion Pump The Curlin Ambulatory Infusion System includes Curlin Ambulatory multi-therapy and PainSmart pumps. Curlin 4000, catalog number 340; Curlin 6000, 6000 CMS, and PainSmart IOD, catalog number 360; and Curlin Pump Calibration Set, catalog number 340-4038.
FDA Recall
Terminated
·MOOG Medical Devices Group·Product code FRN·December 23, 2015
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating Luer, Item No. B9897. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·August 19, 2014
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Luer, Item No. Z2648. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·August 19, 2014
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9801. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·August 19, 2014
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Controller, Rotating Luer, Item No. 011-C9802. Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code FMG·August 19, 2014
Trifurcated Transpac IV Monitoring Kit w/Safeset Reservoir, 03 ml Squeeze Flush and 6 Needleless Valves, Item No. 011-46106-22 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Single Line Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, CSP and Blue Stripe Tubing, Item No. 011-46108-38 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Transpac IT w/3 ML/HR Macrodrip, Arterial Pressure Tubing and CSP, Item No. 011-46106-96 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Arterial Transpac IT Monitoring Kit w/Safeset Reservoir, 03 ml Flush Device and 2 CSP, Item No. 011-46106-72 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Transpac IT w/10 cc Safeset Reservoir, 03 ml Flush Device, 2 CSP and Red Stripe Tubing, Item No. 011-46112-21 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Transpac IV Trifurcated Monitoring Kit w/84" Safeset Reservoir, 03 ml Squeeze Flush and 2 Clave Sampling Ports, Item No. 46112-52 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Trifurcated Transpac IT Monitoring Kit w/03 ml Flush Devices, Needleless Valve and Macrodrip, Item No. 011-46104-33 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014
Single Transpac IT Monitoring Kit w/03 ml Flush Device, Needleless Valve, Macrodrip, Item No. 011-46106-29 Transpac Trifurcated monitoring kit with Safeset Reservoir, squeeze flush and sampling ports. The monitoring kit is intended for measuring and montoring of fluid pressure, fluid infusion, and blood withdrawal.
FDA Recall
Terminated
·ICU Medical, Inc.·Product code DRS·July 18, 2014